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Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00054353
First Posted: February 6, 2003
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Marco Mielcarek, Fred Hutchinson Cancer Research Center
Results First Submitted: April 11, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Refractory Multiple Myeloma
Interventions: Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: mycophenolate mofetil
Drug: cyclosporine
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Related Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).

fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO

cyclosporine: Given PO

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

laboratory biomarker analysis: Correlative s

Unrelated Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).

fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO

cyclosporine: Given PO

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

laboratory biomarker analysis: Correlative s


Participant Flow:   Overall Study
    Related Donor   Unrelated Donor
STARTED   12   4 
COMPLETED   12   4 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Related Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).

fludarabine phosphate: Given IV melphalan: Given IV

total-body irradiation: Undergo TBI

mycophenolate mofetil: Given PO

cyclosporine: Given PO

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

laboratory biomarker analysis: Correlative s

Unrelated Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).

fludarabine phosphate: Given IV melphalan: Given IV

total-body irradiation: Undergo TBI

mycophenolate mofetil: Given PO

cyclosporine: Given PO

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT

laboratory biomarker analysis: Correlative s

Total Total of all reporting groups

Baseline Measures
   Related Donor   Unrelated Donor   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   4   16 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  83.3%      3  75.0%      13  81.3% 
>=65 years      2  16.7%      1  25.0%      3  18.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      12 100.0%      4 100.0%      16 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   8   4   12 
Italy   4   0   4 


  Outcome Measures
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1.  Primary:   PFS   [ Time Frame: At 1 year post-transplant ]

2.  Primary:   Non-relapse Mortality   [ Time Frame: At day 100 ]

3.  Primary:   Incidence of Acute GVHD (Grades III-IV)   [ Time Frame: Up to 5 years ]

4.  Primary:   Incidence of Chronic (Extensive) GVHD   [ Time Frame: Up to 5 years ]

5.  Secondary:   OS   [ Time Frame: At 6 months and then every year thereafter, up to 5 years ]

6.  Secondary:   Engraftment   [ Time Frame: Up to 5 years ]

7.  Secondary:   Relapse Rate   [ Time Frame: Up to 5 years ]

8.  Secondary:   Response Rate   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marco Mielcarek, MD
Organization: Fred Hutch
e-mail: mmielcar@fredhutch.org



Responsible Party: Marco Mielcarek, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00054353     History of Changes
Other Study ID Numbers: 1743.00
NCI-2011-00386 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1743.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: April 11, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017